Linked area parameter adjustment for spinal cord stimulation and associated systems and methods

• US 9,409,019 B2
• Filed: 02/09/2015
• Issued: 08/09/2016
• Est. Priority Date: 07/28/2009
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Walker, Andre B., Parker, Jon
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/617,745
• Publication Number:
  US 20150217113A1
• Time in Patent Office: 547 Days
• Field of Search: 607/2, 607/46, 607/116
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Systems and methods for managing pain in a patient using an electrical waveform that link the modulation of a waveform parameter for different areas of a patient. One embodiment in a system for managing pain in a patient comprises an electric device configured to be implanted into the patient and including a plurality of electrodes having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient. The system further includes an implantable device configured to be coupled to the electrode device and having a computer-operable medium programmed to change the waveform parameter applied to the first electrode and automatically set the waveform parameter applied to the second electrode based on a relationship between a first therapy range and a second therapy range of the waveform parameter.

Claims

1. A system for managing pain in a patient, using an electrical waveform, comprising:

an electrode device configured to be implanted into a patient and including a plurality of electrodes having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient, wherein the first area has a first therapy range for a waveform parameter and the second area has a second therapy range for the waveform parameter; and

an implantable device configured to be coupled to the electrode device, the implantable device including a waveform generator configured to generate a non-paresthesia-producing therapy signal, and a computer-operable medium operatively coupled to the waveform generator, the computer-operable medium being programmed to—

direct the non-paresthesia-producing therapy signal to the electrode device with a frequency from 1.5 kHz to 100 kHz;

change a level of a waveform parameter applied to the first electrode; and

automatically set a level of the waveform parameter applied to the second electrode, based on a scaling factor relating the first therapy range to the second therapy range.

2. The system of claim 1 wherein the scaling factor is a ratio of the second therapy range to the first therapy range.

3. The system of claim 1 wherein the therapy ranges are ranges of the waveform parameter that provide a therapeutic effect without inducing discomfort.

4. The system of claim 1 wherein the computer-operable medium is programmed to:

change the waveform parameter applied to the first electrode by a first increment; and

change the waveform parameter applied to the second electrode by a second increment, the second increment being proportional to a ratio of the second therapy range to the first therapy range.

5. The system of claim 1 wherein the computer-operable medium is programmed to receive a plurality of change command inputs, and wherein:

the scaling factor is a ratio of the second therapy range to the first therapy range;

the waveform parameter applied to the first electrode is changed by a first increment for each change command input; and

for each change command input, the waveform parameter applied to the second electrode is set by (a) changing the waveform parameter applied to the second electrode by the first increment or (b) holding the waveform parameter applied to the second electrode constant.

6. The system of claim 1 wherein the computer-operable medium is programmed to prevent the waveform parameter applied to the first electrode from exceeding a first maximum and prevent the waveform parameter applied to the second electrode from exceeding a second maximum.

7. The system of claim 1 wherein the waveform parameter comprises a waveform amplitude.

8. The system of claim 1 wherein the waveform parameter comprises an impedance between a remote electrode and each of the first electrode at the first area and the second electrode at the second area.

9. The system of claim 1 wherein the waveform parameter comprises waveform power.

10. The system of claim 1 wherein:

the first therapy range corresponds to a difference between (a) a first sensation threshold and/or a first therapeutic threshold and (b) a first discomfort threshold for the first area; and

the second therapy range corresponds to a difference between (a) a second sensation threshold and/or a second therapeutic threshold and (b) a second discomfort threshold for the second area.

11. The system of claim 1 wherein the computer-operable medium is programmed to:

store diagnostics including a plurality of observed patient usage patterns; and

transmit the diagnostics of observed patient usage patterns to a remote processor that determines the first therapy range, the second therapy range, and a ratio of the second therapy range to the first therapy range.

12. The system of claim 1 wherein the computer-operable medium is programmed to:

determine a first ratio of the second therapy range to the first therapy range associated with a first patient position;

determine a second ratio of the second therapy range to the first therapy range associated with a second patient position; and

change the waveform parameter applied to the first and second electrodes based on the first ratio when the patient is in the first position or based on the second ratio when the patient is in the second position.

13. The system of claim 1 wherein the computer-operable medium is programmed to:

receive a first maximum for the waveform parameter applied to the first electrode and set a second maximum for the waveform parameter applied to the second electrode; and

decouple the second electrode from the first electrode for adjustment of the parameter when one of the first or second electrodes has reached the first or second maximum, respectively.

14. The system of claim 1 wherein the computer-operable medium is programmed to:

change the waveform parameter applied to the first electrode by a first increment; and

change the waveform parameter applied to the second electrode by a second increment, wherein the second increment is the product of the first increment and a ratio of the second therapy range to the first therapy range.

15. A spinal cord modulation system, comprising:

a signal delivery device having a proximal portion and a distal portion, wherein the distal portion includes a plurality of electrodes having at least a first electrode associated with a first area of the patient and a second electrode associated with a second area of the patient, wherein the first area has a first therapy range for a waveform parameter and the second area has a second therapy range for the waveform parameter; and

a pulse generator coupleable to the proximal portion of the signal delivery device and programmed with instructions that, when executed;

generate and transmit to the signal delivery device a non-paresthesia-producing therapy signal having a frequency in a frequency range of 1.5 kHz to 100 kHz;

change a level of a waveform parameter applied to the first electrode; and

automatically set a level of the waveform parameter applied to the second electrode, based on a relationship between the first therapy range and the second therapy range.

16. The system of claim 15 wherein the relationship includes a scaling factor relating the first therapy range to the second therapy range.

17. The system of claim 16 wherein the scaling factor is a ratio of the second therapy range to the first therapy range.

18. The system of claim 15 wherein the therapy signal has an amplitude between 0.1 mA and 20 mA.

19. The system of claim 15 wherein the therapy signal has a plurality of biphasic pulses having a pulse width between 10 microseconds and 333 microseconds.

20. The system of claim 15, wherein the pulse generator is an implantable pulse generator.

21. The system of claim 15, wherein the pulse generator is an external pulse generator.

22. The system of claim 15, wherein the signal delivery device includes an elongated lead.

23. The system of claim 15, wherein the signal delivery device includes a paddle lead.

24. The system of claim 15 wherein the pulse generator is programmed to:

change the waveform parameter applied to the first electrode by a first increment; and

change the waveform parameter applied to the second electrode by a second increment, the second increment being proportional to a ratio of the second therapy range to the first therapy range.

25. The system of claim 15 wherein the pulse generator is programmed to receive a plurality of change command inputs, and wherein:

the scaling factor is a ratio of the second therapy range to the first therapy range;

the waveform parameter applied to the first electrode is changed by a first increment for each change command input; and

for each change command input, the waveform parameter applied to the second electrode is set by (a) changing the waveform parameter applied to the second electrode by the first increment or (b) holding the waveform parameter applied to the second electrode constant.

26. The system of claim 15 wherein the pulse generator is programmed to prevent the waveform parameter applied to the first electrode from exceeding a first maximum and prevent the waveform parameter applied to the second electrode from exceeding a second maximum.

27. The system of claim 15 wherein the waveform parameter comprises a waveform amplitude.

28. The system of claim 15 wherein the waveform parameter comprises an impedance between a remote electrode and each of the first electrode at the first area and the second electrode at the second area.

29. The system of claim 15 wherein the waveform parameter comprises waveform power.

30. The system of claim 15 wherein:

the first therapy range corresponds to a difference between (a) a first sensation threshold and/or a first therapeutic threshold and (b) a first discomfort threshold for the first area; and

the second therapy range corresponds to a difference between (a) a second sensation threshold and/or a second therapeutic threshold and (b) a second discomfort threshold for the second area.

31. The system of claim 15 wherein the pulse generator is programmed to:

store diagnostics including a plurality of observed patient usage patterns; and

transmit the diagnostics of observed patient usage patterns to a remote processor that determines the first therapy range, the second therapy range, and a ratio of the second therapy range to the first therapy range.

32. The system of claim 15 wherein the pulse generator is programmed to:

determine a first ratio of the second therapy range to the first therapy range associated with a first patient position;

determine a second ratio of the second therapy range to the first therapy range associated with a second patient position; and

change the waveform parameter applied to the first and second electrodes based on the first ratio when the patient is in the first position or based on the second ratio when the patient is in the second position.

33. The system of claim 15 wherein the pulse generator is programmed to:

receive a first maximum for the waveform parameter applied to the first electrode and set a second maximum for the waveform parameter applied to the second electrode; and

decouple the second electrode from the first electrode for adjustment of the parameter when one of the first or second electrodes has reached the first or second maximum, respectively.

34. The system of claim 15 wherein the pulse generator is programmed to:

change the waveform parameter applied to the first electrode by a first increment; and

change the waveform parameter applied to the second electrode by a second increment, wherein the second increment is the product of the first increment and a ratio of the second therapy range to the first therapy range.